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510(k) Data Aggregation

    K Number
    K191732
    Date Cleared
    2019-08-30

    (63 days)

    Product Code
    Regulation Number
    878.4400
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    Sutter RaVoR Bipolar Electrodes

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Sutter RaVoR™ Bipolar Electrodes are to be connected to the Sutter CURIS® RF Generator. Sutter RaVoR™ Bipolar Electrodes are indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery.
    The RaVoR™ Bipolar Electrode for the soft palate is indicated for submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring.
    The RaVoR™ Bipolar Electrode for the turbinates is indicated for submucosal tissue shrinkage for reduction of hypertrophic nasal turbinates in patients with nasal turbinate airway obstruction.

    Device Description

    Sutter RaVoR™ Bipolar Electrodes are electrosurgical instruments available in different angled sheath configurations. They are to be connected to the bipolar output of the Sutter CURIS® RF Generator. The electrodes are provided sterile and are single-use devices.

    AI/ML Overview

    The Sutter RaVoR™ Bipolar Electrodes are not an AI device, therefore, the information requested is not available in the provided text. The document refers to the device as an electrosurgical instrument for soft tissue ablation and coagulation in ENT surgery. It describes non-clinical performance data and concludes substantial equivalence to a predicate device, but does not pertain to AI/ML or require the typical acceptance criteria and study designs associated with AI devices.

    However, based on the provided text, here is a breakdown of the non-clinical performance data and the study types conducted to demonstrate substantial equivalence:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are generally implied by "Pass" for each test, indicating that the device met the design specifications and performance requirements.

    Test TypeAcceptance Criteria (Implied)Reported Device Performance
    Electromagnetic Compatibility and Electrical SafetyPass relevant IEC standardsPass
    Mechanical StrengthMeet strength requirementsPass
    System Performance / Bench-top validation testingMeet performance requirementsPass
    Thermal effects on tissueMeet thermal effect targetsPass
    Transport and StorageMaintain functionalityPass
    Sterility Assurance Level (SAL)10⁻⁶10⁻⁶
    Shelf LifeUp to 3 yearsUp to 3 years
    BiocompatibilityCompliance to ISO 10993-1Performed
    Thermal damage / thermal spread testingComparable to predicateComparable to predicate

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not specify a distinct "test set" in the context of an AI device. Instead, it refers to a series of bench tests.

    • Sample Sizes: Not explicitly stated for each bench test. For "Thermal damage / thermal spread testing," experiments were performed for both the subject and predicate device, implying multiple tests or observations to draw comparisons.
    • Data Provenance: The data is from "Bench Testing" and "Non-Clinical Performance Data" conducted by the applicant, Sutter Medizintechnik GmbH. This is laboratory-based testing, not human data.

    3. Number of Experts Used to Establish Ground Truth and Their Qualifications

    Not applicable, as this is not an AI device and the ground truth for performance was established through engineering and scientific testing standards rather than expert consensus on medical images or patient outcomes.

    4. Adjudication Method

    Not applicable. The performance was assessed against technical standards and benchmarks, not through expert adjudication of results.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    Not applicable. No MRMC study was conducted as this device is not an AI algorithm requiring human-in-the-loop performance evaluation.

    6. Standalone (Algorithm Only) Performance Study

    Not applicable. This is a medical device, not an AI algorithm.

    7. Type of Ground Truth Used

    The "ground truth" for the device's performance was established through:

    • Engineering Standards: Compliance with international standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 11137-1, ISO 11137-2, and ISO 10993-1.
    • Benchmarking against Predicate Device: Comparison of thermal effects, lesion size, and cool-down time to the legally marketed predicate device (Celon AG medical instruments, Celon ENT System, K032838).
    • Laboratory Measurements: Direct measurements of physical properties, electrical characteristics, and biological interactions in controlled environments.

    8. Sample Size for the Training Set

    Not applicable. There is no training set mentioned as this is not an AI/ML device.

    9. How the Ground Truth for the Training Set was Established

    Not applicable. No training set was used.

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